CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 7, 2021—Amgen announced FDA approval of Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
The approval of Lumakras is based on results from a subset of patients in CodeBreaK 100, the largest clinical trial conducted exclusively for patients with the KRAS G12C mutation. The trial demonstrated favorable efficacy and tolerability in 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. In the trial, 960 mg of Lumakras administered orally once daily demonstrated an overall response rate (a proportion of patients with ≥ 30 percent decrease in tumor) of 36 percent (95 percent CI, 28–45) with 81 percent (95 percent CI, 73–87) of patients achieving disease control. The median duration of response was 10 months.
Lumakras received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial or trials.